SII seeks Emergency Use Authorisation for Covovax vaccine from DCGI

The Serum Institute of India on Friday sought permission from the Drugs Controller General of India (DCGI) to provide emergency use authorization to the COVID-19 vaccine Covovax, based on the US-based Novovax's protein vaccine.

After Covishield, the Serum Institute of India has sought emergency use authorization in India from the Drug Controller General of India (DCGI) for another COVID-19 vaccine, Covovax. The Pune based Serum Institute is manufacturing the Covovax in its Manjari manufacturing site. Covovax is Adar Poonawalla-helmed SII’s version of the protein-based COVID-19 vaccine developed by Novavax, USA.

SII submits reports of phase 2/3 clinical trials to DCGI for emergency use of Covovax

Along with its application, the company filed an interim phase 2/3 clinical research report on Indian adults, as well as an interim report on Novavax UK and USA-Mexico phase-3 clinical study to provide sufficient data to answer DCGI's questions. As per the PTI report, the study data raised no safety concerns, and Covovax is safe and immunogenic in adults, emphasized Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), who had sent the application to the DCGI.

"In our government's endeavour to fight against COVID-19 pandemic, we have also been working shoulder to shoulder with the Government of India to make available one more safe and efficacious world-class COVID-19 vaccine for our country and the world at large. Approval of our COVOVAX and its availability will further strengthen India's capability to fight the COVID-19 pandemic and ensure vaccine security in line with our prime minister's clarion call of Atmanirbhar Bharat," PTI report mentions an official source quoted Singh as having said in the application.

In the phase 2/3 study in India, more than 1,400 participants have received at least the first dose of the vaccine with no safety concerns reported so far, stated the application. In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of its COVID-19 vaccine candidate, in low and middle-income countries and India.

Adar Poonawalla’s Serum Institute, which manufactures COVID-19 vaccine Covishield, will produce Covovax at its Manjari plant in Maharashtra on a larger scale. Serum Institute of India has also sought a partnership with Russia, to manufacture Sputnik V in India. Serum Institute plans to produce three types of COVID-19 vaccine by November end, expanding its capacity to 250 million doses a month.

With PTI Inputs

Image: PTI/ Twitter